Lee 2001a.
Study characteristics | ||
Methods | Study design: double‐blind, randomised Country: Taiwan Setting: single centre Intention‐to‐treat: not mentioned |
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Participants | Number of participants randomly assigned: 50 Number of participants analysed: 50 Exclusions postrandomisation: 0 Losses to follow‐up: 0 Age (mean): cilostazol: 66 (SD 9) years, pentoxifylline: 68 (SD 5) years, placebo: 69 (SD 6) years Sex: male:female: cilostazol: 14/3, pentoxifylline: 14/3, placebo: 14/2 Inclusion criteria: aged > 40 years; stable PAD for ≥ 3 months; baseline maximum walking distance > 30 m and < 200 m; variance < 20% in maximum walking distance in the 2 screening tests Exclusion criteria: Buerger's disease; category II or III chronic lower limb ischaemia; arterial surgery/angioplasty or sympathectomy within previous 3 months |
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Interventions | Treatment: oral pentoxifylline, 400 mg twice bid Control 1: oral cilostazol, 100 mg bid Control 2: placebo Duration: 8 weeks |
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Outcomes | Primary: mean TWD Secondary: ABI, side effects |
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Notes | Treadmill protocol: 3.2 km/h at 12.5% gradient Mean TWD expressed in metres only |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomised code number according to which sponsor supplied the study drug." |
Allocation concealment (selection bias) | Low risk | Sealed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Special drug packaging was used to maintain the blindness of the treatment code." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete outcome data. |
Selective reporting (reporting bias) | Unclear risk | Protocol not available; insufficient information available to permit judgement. |
Other bias | Low risk | Study appeared free of other bias. |